Study of TVEC in Patients With Cutaneous Squamous Cell Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cutaneous Tumor
- Keratoacanthoma
- Lesion Skin
- Skin Cancer
- Skin Cancer, Squamous Cell
- Squamous Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The purpose of this study is to find out more about talimogene laherparepvec (also known as OncoVEXGM-CSF or IMLYGIC®) in people with a healthy immune system with confirmed low-risk squamous cell carcinoma. Usually, low-risk SCC is treated with a surgical procedure, but surgery can be challenging wh...
The purpose of this study is to find out more about talimogene laherparepvec (also known as OncoVEXGM-CSF or IMLYGIC®) in people with a healthy immune system with confirmed low-risk squamous cell carcinoma. Usually, low-risk SCC is treated with a surgical procedure, but surgery can be challenging when patients have: multiple SCCs on their body, when the SCC is on a challenging place on the body to remove or when patients are older or have diseases that place them at risk for surgery related complications. Immune therapy is a treatment that uses certain parts of a person's immune system to fight disease. Immune therapy is a proven therapeutic approach in many cancers, including melanoma, another type of skin cancer. Talimogene laherparepvec (TVEC) is made from a modified herpes simplex virus type 1 (HSV-1, the "cold sore" virus). The virus' genes were modified in a laboratory so that it produces a protein called human granulocyte macrophage colony-stimulating factor (GM-CSF), which multiplies and grows in tumor cells. Human GM-CSF is normally produced by various cells within the body and is used as a medicine to treat patients with white blood cell counts that are too low. This modified HSV-1 produces a protein that acts on tumor cells and stimulates the immune system. TVEC is administered by injection with a needle directly into one or more tumors and works by directly destroying cancer cells and enhancing immune response to destroy cancer cells.
Tracking Information
- NCT #
- NCT03714828
- Collaborators
- Amgen
- Investigators
- Principal Investigator: Clara Curiel, MD University of Arizona